Abstract:

There is provided a biosensor chip where the collecting amount necessary
for the measurement is made small whereby burden of a user is reduced
and, at the same time, a sample at a puncture opening is able to be
easily collected and measured without an operation of making the sample
collection opening nearer the puncture opening. When an end of a main
body chip is pushed onto a test body, an elastic body installed at an end
of the main body chip is compressed and a device for puncture is produced
whereby the test body is able to be punctured. When the pushing force is
made weak, the device for puncture is pulled out from the test body due
to resilience of the elastic body and a sample is flown out from the
puncture opening. At that time, since the puncture opening and the sample
collection opening installed in the main body chip are enclosed in a
tightly-closed space formed by the elastic body, even small amount of the
sample is able to be easily collected by the sample collection opening
without conducting the positioning of the sample collection opening.

Claims:

1-7. (canceled)

8. A biosensor chip comprising:a chip main body, including substrate
plates located opposite each other and a spacer layer sandwiched by the
substrate plates,electrodes for detection formed on a surface of at least
one of the substrate plates on the spacer layer side,a device for
puncture fixed to an end of the chip main body,a hollow reaction area,
defined by the spacer layer and the substrate plate to which the
electrodes for detection are exposed, in which a sample collection
opening is formed at a front end for the introduction of a collected
sample, and a reagent that reacts with the sample is arranged immediately
above or in the vicinity of the electrodes for detection, andan elastic
body installed at the end of the chip main body.

9. The biosensor chip according to claim 8, whereinthe device for puncture
is fixed to one end of the spacer layer or to one end of an external side
wall of one of the substrate plates.

10. The biosensor chip according to claim 8, whereinthe elastic body is
provided with a space in which the device for puncture is capable to
smoothly suck a sample after the puncture.

11. The biosensor chip according to claim 8, whereina sample collection
opening formed at a front end of the chip main body and a puncture
opening formed on a test body by the device for puncture are connected by
a tightly-closing and semi-opening space.

12. The biosensor chip according to claim 8, whereinthe device for
puncture is projected at the end.

13. The biosensor chip according to claim 8, further comprising:a driving
mechanism which punctures the device for puncture into a test body.

14. A method for collecting a sample, comprising the steps of:preparing
the biosensor chip according to claim 8,puncturing the elastic body by
means of compression by pushing to the test body,collecting a sample with
forming a flow path, andpulling the device for puncture out of the test
body by resilience of the elastic body.

15. A biosensor system, comprising:the biosensor chip according to claim
8, anda measuring device receiving information of collected sample by
connecting to the electrodes for detection of the biosensor chip.

Description:

TECHNICAL FIELD

[0001]The present invention relates to a biosensor chip and, for example,
it relates to a biosensor chip which conducts measurement and analysis of
chemical substances using a reagent received in a hollow reacting part of
the chip.

RELATED ART

[0002]There has been already known a biosensor chip which detects, for
example, the concentration of glucose in blood (refer, for example, to
Patent Document 1).

[0004]As shown in FIG. 9, the glucose sensor 100 which is a biosensor has
a pair electrode 101 and a working electrode 102. The pair electrode 101
has a hollow needle shape which is cut into half in the longitudinal
direction and its front end 103 is obliquely cut in a needle shape so as
to easily puncture. The surface cut into half is applied with insulating
layers 104, 104' which also act as adhesive layers such as an epoxy resin
adhesive, a silicone adhesive or glass and the working electrode 102 is
installed via the insulating layers 104, 104'. The working electrode 102
is a material in a flat plate shape where glucose oxidase (GOD) is fixed
and is adhered to the pair electrode 101 where the side in which GOD is
fixed is turned inside. Accordingly, the front end 103 of the
needle-shaped pair electrode 101 is punctured to a person to be tested to
collect blood and the reaction of the collected blood with the fixed GOD
105 is detected by the working electrode 102 whereupon a quantitative
determination of glucose is carried out.

[0005]There is also disclosed a biosensor in which biosensor chip and
lancet are integrated (refer, for example, to Patent Document 2).

[0006]FIG. 10(A) is an oblique view of the sensor mentioned in Patent
Document 2 and FIG. 10(B) is a disassembled oblique view of the sensor.
As shown in FIG. 10, a sensor 110 integrated with a lancet has a chip
main body 111, a lancet 113 and a protective cover 115. The chip main
body 111 has a cover 111a and a substrate 111b in a freely openable
manner and an internal space 112 is formed in the inner side of the cover
111a. The internal space 112 has such a shape which is able to receive
the lancet 113 in a movable manner.

[0007]A needle installed at the front end of the lancet 113 is able to
come in and out at an opening 112a formed at the front end of the
internal space 112 of the chip main body 111 as the lancet 113 moves. The
shape of the internal space 111a is curved at the end where the
projection 113a is positioned so that its width becomes somewhat narrower
than the lancet 113 and the lancet 113 is locked by the chip main body
111 by the pushing force and the abrasive force of them. A protective
cover 115 has a pipe 115a into which a needle 114 is inserted and, as the
needle 114 moves, the pipe 115a is also able to be received in the inner
area of the chip main body 111. Accordingly, in the state before actual
use, the protective cover 115 is covered on the needle 114 so that it
protects the needle 114 and does not erroneously injure a user. In the
substrate 111b, a pair of electrode terminals 116 is installed so that it
is able to be electrically connected to a measuring device (not shown).

[0008]In use, the protective cover 115 is detached and the lancet 113 is
pushed so that the needle 114 is projected out from the chip main body
111. A sample body is punctured under this state, then the needle 114 is
received in the inner area of the chip main body 111, an opening 112a
installed at the front end of the chip main body 111 is brought nearer to
the puncture opening and the blood flown out therefrom is collected.

[0009]However, since a needle-shaped pair of electrodes 101 and a working
electrode 102 are formed by adhesion in the glucose sensor mentioned in
Patent Document 1, diameter of the puncture needle becomes as big as in
the same size as the width of the glucose sensor 100. Therefore, there
are problems that the amount of the collecting blood becomes too much and
pain upon puncture is high whereby the burden of the user becomes big.

[0010]Moreover, in a sensor 110 which is integrated with a lancet as
mentioned in Patent Document 2, it has a structure where the blood flown
out from the puncture opening is absorbed from an opening 112a and such a
structure is complicated.

[0011]The present invention is achieved in view of the above-mentioned
problems and its object is to provide a biosensor in which the collecting
amount of a sample necessary for the measurement is made small so that
burden of a user is reduced and, at the same time, a sample at the
puncture opening is able to be collected and measured without conducting
an operation of bringing the sample collection opening nearer to the
puncture opening.

Means for Solving the Problems

[0012]In order to achieve the above-mentioned object, according to a first
aspect of the invention, there is provided a biosensor chip, including:

[0013]a chip main body, including substrate plates located opposite each
other and a spacer layer sandwiched by the substrate plates;

[0014]electrodes for detection, formed on a surface of at least one of the
substrate plates on the spacer layer side;

[0015]a device for puncture, fixed to an end of the chip main body;

[0016]a hollow reaction area, defined by the spacer layer and the
substrate plate to which the electrodes for detection are exposed, in
which a sample collection opening is formed at a front end for the
introduction of a collected sample, and a reagent that reacts with the
sample is arranged immediately above, or in the vicinity of, the
electrodes for detection; and

[0019]When an end of the chip main body is pushed to a test body in the
biosensor chip constituted as such, an elastic body installed at an end
of the chip main body is compressed and a device for puncture is
projected whereby the test body is able to be punctured. When a pushing
pressure made weak, the device for puncture is pulled out from the test
sample due to resilience of the elastic body whereupon the sample is
flown out from the puncture opening. Incidentally, when puncture is
carried out in case the inner area of the protective cap covering the
chip main body is in a reduced pressure, a sample is efficiently flown
out therefrom.

[0020]According to a second aspect of the invention, there is provided the
biosensor chip according to the first aspect, wherein the device for
puncture is fixed to one end of the spacer layer, or to one end of an
external side wall of one of the substrate plates.

[0021]According to this arrangement of the biosensor chip, when the
puncture device is fixed to one end of the spacer layer, a sample
collection opening can be formed near the puncture device, and thus, a
collected sample can be directly introduced, through the sample
collection opening, into the hollow reaction area. When the device for
puncture is fixed to one end of the external side wall of one of the
substrate plates, the thickness of the chip main body can be reduced.

[0022]Furthermore, according to a third aspect of the invention, there is
provided the biosensor chip according to the first or second aspect,
wherein the elastic body provides a space in which the device for
puncture is capable to suck a sample after the puncture.

[0023]In the biosensor chip constituted as such, suction of the sample
after the puncture is able to be conducted via a space of the elastic
body whereby it is now possible to suck the sample smoothly even when the
amount of the sample is small.

[0024]Moreover, according to a fourth aspect of the invention, there is
provided the biosensor chip according to any one of the first to the
third aspects, wherein a sample collection opening formed at a front end
of the chip main body and a puncture opening formed on a test body by the
device for puncture are connected by a tightly-closing and semi-opening
space.

[0025]In the biosensor chip constituted as such, a puncture opening and a
sample collection opening installed at the front end of a chip main body
are connected by a tightly-closing and semi-opening space formed by an
elastic body whereby, upon the puncture, even small amount of the sample
is able to be easily collected by the sample collection opening.
Incidentally, when the device for puncture is not made projected out from
an end of the elastic body before use, protection of the device for
puncture and protection of users are able to be achieved. Further, when
the device for puncture is not made projected out from an end of the
elastic body in disposal after use, it is also possible to dispose safely
and appropriately.

[0026]Furthermore, according to a fifth aspect of the invention, there is
provided the biosensor chip according to any one of the first to the
fourth aspects, wherein the device for puncture is projected at the end.

[0027]In the biosensor chip constituted as above, there is a
characteristic feature that, since the device for puncture is projected
at one end, the sample is able to be easily collected.

[0028]According to a sixth aspect of the invention, there is provided the
biosensor chip according to any one of the first to the fifth aspects,
further including:

[0029]a driving mechanism which punctures the device for puncture into a
test body.

[0030]In the biosensor chip constituted as such, time for the puncture is
able to be made short by puncturing the device for puncture into a test
body by means of a driving mechanism, it is now possible to reduce the
pain upon collecting the sample.

[0031]According to a seventh aspect of the invention, there is provided a
method for collecting a sample, including the steps of:

[0032]preparing a biosensor chip according to any one of the first to the
sixth aspects;

[0033]puncturing the elastic body by means of compression by pushing to
the test body;

[0034]collecting a sample with forming a flow path; and

[0035]pulling the device for puncture out of the test body by resilience
of the elastic body.

[0036]In the sample collection method constituted as such, the elastic
body installed at an end of the biosensor chip is pushed onto the test
body, the elastic body is compressed and the device for puncture is
projected from the front end of the elastic body whereby the device for
puncture is pulled out by resilience of the elastic body after the
puncture. As a result, analysis using a small amount of the sample is
possible whereby burden of the test body is able to be reduced.

[0037]According to an eighth aspect of the invention, there is provided a
biosensor system including:

[0038]the biosensor chip according to any one of the first to the sixth
aspects; and

[0039]a measuring device receiving information of collected sample by
connecting to the electrodes for detection of the biosensor chip.

[0040]In the biosensor system constituted as such, a sample is collected
by the above-mentioned biosensor chip and information of the sample is
transmitted to a measuring device via the detecting electrodes whereby
the measurement is able to be conducted easily within short time and, as
a result, burden of a test body is able to be reduced.

Effects of the Invention

[0041]In accordance with the present invention, an elastic body is
installed at an end of the chip main body and, as a result, when an end
of the chip main body is pushed onto a test body, the elastic body
installed at an end is compressed and the device for puncture is
projected whereby it is able to puncture the test body. When the pushing
force is made weak, the device for puncture is pulled out from the test
body due to resilience of the elastic body whereby a sample is flown out
from the puncture opening. Since a puncture opening and the sample
collection opening installed at the front end of the chip main body are
enclosed in a tightly-closing and semi-opening space formed by the
elastic body whereby even a small amount of the sample is able to be
easily collected by the sample collection opening and burden of a test
body is able to be reduced.

BRIEF DESCRIPTION OF DRAWINGS

[0042]FIG. 1(A) is an explanatory drawing which shows an embodiment of the
biosensor chip according to the present invention, and FIG. 1(B) is an
explanatory drawing which shows an embodiment of the biosensor chip
according to the present invention.

[0043]FIG. 2 is a plane figure which shows an embodiment of the biosensor
system according to the present invention.

[0044]FIGS. 3(A) to (C) are explanatory drawings which show an operation
of measurement of blood sugar level using the biosensor system according
to the present invention.

[0045]FIG. 4(A) is an explanatory drawing which shows another embodiment
of the biosensor chip according to the present invention, and FIG. 4(B)
is an explanatory drawing which shows another embodiment of the biosensor
chip according to the present invention.

[0046]FIG. 5(A) is a drawing which shows another embodiment of the elastic
body used in the biosensor chip according to the present invention, and
FIG. 5(B) is a drawing which shows another embodiment of the elastic body
used in the biosensor chip according to the present invention.

[0047]FIG. 6(A) is a drawing which shows still another embodiment of the
elastic body used in the biosensor chip according to the present
invention, and FIG. 6(B) is a drawing which shows a modified example of
FIG. 6(A).

[0048]FIG. 7(A) is a drawing which shows still another embodiment of the
elastic body used in the biosensor chip according to the present
invention, and FIG. 7(B) is a drawing which shows another embodiment of
the elastic body used in the biosensor chip according to the present
invention.

[0049]FIG. 8 is a drawing which shows still another embodiment of the
elastic body used in the biosensor chip according to the present
invention.

[0050]FIG. 9 is a disassembled oblique view which shows the conventional
biosensor chip.

[0051]FIG. 10(A) is an oblique view which shows the conventional biosensor
chip, and FIG. 10(B) is a disassembled oblique view which shows the
conventional biosensor chip.

DESCRIPTION OF REFERENTIAL NUMERALS

[0052]10 biosensor chip

[0053]11 main body chip

[0054]11a an end

[0055]12 device for puncture

[0056]12a front end

[0057]13 sample collection opening

[0058]14 reagent

[0059]18a, 18b electrodes for detection

[0060]20 elastic body

[0061]21 front end (surface)

[0062]23 tightly-closed space

[0063]24 adhesive

[0064]30 biosensor system

[0065]31 measuring device

[0066]D blood (sample)

[0067]M test body

BEST MODE FOR CARRYING OUT THE INVENTION

[0068]As hereunder, embodiments of the present invention will be
illustrated in detail by referring to the drawings.

[0069]FIG. 1(A) is a cross-sectional view of the position A-A in FIG. 1(B)
which shows an embodiment of the biosensor chip of the present invention;
FIG. 1(B) is a cross-sectional view of the position B-B in FIG. 1(A)
which shows an embodiment of the biosensor chip of the present invention;
FIG. 2 is a constitutional drawing which shows an embodiment of the
biosensor system of the present invention; and FIG. 3(A) to (C) are
explanatory drawings which show a collecting operation of a sample using
the biosensor system according to the present invention.

[0070]As shown in FIG. 1(A) and (B), the biosensor chip 10 which is an
embodiment of the present invention has a chip main body 11 and a device
for puncture 12 for the puncture which is fixed to an end 11a of the chip
main body 11 where a front end thereof 12a is projected. An elastic body
20 which forms, upon pushing onto a test body M, a sample collection
opening 13 installed at an end 11a of the chip main body 11 and a
tightly-closing and semi-opening space 23 by enclosing a puncture opening
formed on the test body M by a device for puncture 12 is installed at an
end 11a of the chip main body 11.

[0071]The tightly-closing and semi-opening space 23 becomes a
tightly-closed one when an elastic body 20 is pushed onto a test body
whereby the sample is able to be easily collected.

[0072]The chip main body 11 has two substrate plates 16a, 16b facing each
other and a spacer layer 17 being sandwiched between the two substrate
plates 16a, 16b. Electrodes for detection 16a, 16b are installed on the
surface of the spacer layer 17 side of at least one substrate plate 16a
of the two substrate plates 16a, 16b and their front ends (the lower ends
in FIG. 1(A)) are bent in an L-shape in the direction of being faced each
other whereby a predetermined space is kept. A hollow reacting area 19 is
formed by the two substrate plates 16a, 16b and the spacer layer 17
throughout the area ranging from an end 11a of the chip main body 11 to
the part where two electrodes for detection 18a, 18b are faced each
other. At the front end of the hollow reacting area 19, there is
installed a sample collection opening 13 by which the blood D (refer to
FIG. 3(C)) is collected as a sample by the device for puncture 12 by
means of puncturing into a test body M (refer to FIG. 3) and introduced
into a hollow reaction area 19.

[0073]Thus, both upper and lowers surfaces of the hollow reacting area 19
are formed by the substrate plates 16a, 16b and the electrodes for
detection 18a, 18 and a rectangular space is formed using a spacer 17
which is cut into a predetermined shape as a side wall. Therefore, the
electrodes for detection 18a, 18b are exposed in the hollow reacting area
19 and, immediately above or near the electrodes for detection 18a, 18b
in the hollow reacting area 19, there is installed a reagent 14 which,
for example, fixes an enzyme and a mediator and generates electric
current by the reaction with glucose in the blood D. Accordingly, the
hollow reacting area 19 is an area where the blood D such as blood taken
thereinto from a sample collection opening 13 is subjected to biochemical
reaction with the reagent 14.

[0074]With regard to an elastic body 20 installed at an end 11a of a chip
main body 11, there may be exemplified a cylindrical one having a
perforation hole 22 for forming a tightly-closing and semi-opening space
23 at the center. Since a device for puncture 12 is inserted into the
perforation hole 22, diameter of the hole is larger than the outer
diameter of the device for puncture 12. Thickness of an elastic body 20
is sufficiently thick so that it is able to surely cover until the front
end of the device for puncture 12. As to a material for the elastic body
20, there is no particular limitation so far as it is elastic and
examples of the applicable one are rubber or sponge including a single
polymer of silicone, urethane, acrylate, ethylene, styrene, etc. or a
copolymer thereof; polyolefin such as polyethylene and polypropylene;
polyester such as polyethylene terephthalate and polybutylene
terephthalate; and fluorine resin such as polytetrafluoroethylene and PFA
which is a copolymer of perfluoroalkoxyethylene with polyfluoroethylene.
The rubber elastomer may be hollow or not.

[0075]It is desirable that the front end 21 which is a surface of the
elastic body contacting the test body M is constituted from a material
such as adhesive silicone rubber, acrylate rubber, etc. or the elastic
body 20 is mixed with or coated with an adhesive 24.

[0076]It is not essential that the front end 21 has adhesive property and
even a material having no adhesive property is able to be substituted for
an adhesive by installing very fine projections for preventing slippage.
As a result, it is now possible that close adhesion of the elastic body
20 with the test body M is improved, that slippage from the puncture
position is prevented and that a tightly closed space 23 is surely
formed.

[0077]Examples of a driving mechanism for puncturing a device for puncture
into a test body are spring and motor. When such a driving mechanism is
used, time needed for the puncture is able to be made short and the pain
upon the puncture is able to be reduced.

[0078]Now the biosensor system according to the present invention will be
illustrated. FIG. 2 shows a constitution of a biosensor system 30 using
the above-mentioned biosensor chip 10.

[0079]As shown in FIG. 2, the biosensor system 30 has the above-mentioned
biosensor chip 10, a measuring device 31 which connects to electrodes for
detection 18a, 18b of the biosensor chip 10 and obtains the information
of blood D collected by connecting and a protective cap 36 for the
biosensor chip. Constitution of the biosensor chip 10 is as mentioned
above and the sites which are common to those in the already-mentioned
biosensor chip 10 are assigned with the same symbols whereby
illustrations thereof will be omitted here.

[0080]The measuring device 31 is equipped with an electric source 32, a
controlling device 33, a terminal insertion area 34 and a display area 35
and they are connected each other. The terminal insertion area 34 is
fixed by being inserted with the rear end 11b of the chip main body 11 of
the biosensor chip 10 and the electrodes for detection 18a, 18b exposed
to the rear end 11c of the chip main body 11 are electrically connected.
This biosensor system 30 is small in size and is a handy type which is,
for example, able to be held by one hand of a test body.

[0081]Now the method of use will be illustrated by taking the case where
sugar blood level is measured using this biosensor system 30 by referring
to FIG. 3(A) to (C).

[0082]Firstly, the rear end 11b of the main body 11 of a biosensor chip 10
is inserted into a terminal insertion part 34 of a measuring device 31 to
fix and to electrically connect as shown in FIG. 2. The electric source
32 of the biosensor system 30 is made on and it is confirmed whether the
system is driven normally. As shown in FIG. 3(A), the biosensor system 30
is held and the protective cap 36 is pushed onto a test body so that the
punctured area is congested with blood and the elastic body 20 attached
to an end 11a of the biosensor chip 10 is contacted to the blood
collection area of the test body M. Since the front end of the elastic
body 20 is coated with an adhesive 24, getting-out of the position during
the operation thereafter is able to be prevented.

[0083]After that, the biosensor chip 10 is pushed onto the test body M as
shown in FIG. 3(B). As a result, the elastic body 20 is crushed and a
device for puncture 12 is projected from the front end of the elastic
body 20 and punctures the test body M.

[0084]When the force of pushing the biosensor chip 20 is made weak as
shown in FIG. 3(C), the elastic body 20 returns to its original state
(the state of FIG. 3(A)) due to the resilience whereby the device for
puncture 12 is detached from the test body M. At that time, inner area of
the tightly-closed space including the puncture opening becomes negative
pressure and, therefore, blood D is apt to be flown out from the puncture
opening. Further, since the inner surface of the penetration hole 22
forming the tightly-closed space 23 is subjected to a hydrophilic
treatment, the blood D is collected from the sample collection opening 13
along the inner surface of the penetration hole 22 due to its surface
tension and capillary phenomenon. The collected blood D is introduced
into a hollow reaction area 19. At that time, the sample collection
opening 13 is positioned in the tightly-closed space 23 together with the
puncture opening formed by the device for puncture 12 and, therefore, the
blood Disable to be collected easily and surely without moving the
biosensor chip 10. As a result, even a test body M with poor eyesight is
able to use it and, further, the measurement is possible using small
amount of blood whereupon burden of the test body upon collection of the
blood is able to be reduced. In addition, since the tightly-closing and
semi-opening space 23 is shut out from the air outside, coagulation of
the blood D is retarded whereby its collection is able to be made easier.

[0085]When a predetermined amount of blood is collected, the biosensor
system 30 is detached from the test body M and one waits until the
measured result is shown on a display 35. The blood D which is introduced
into the hollow reacting part 19 reacts with the reagent 14 and the data
of electric current or electric charge (charge amount) measured by the
electrodes for detection 18a, 18b are sent to a controlling device 33. A
calibration curve data table is received in the controlling device 33 and
then the calculation of blood sugar level is conducted on the basis of
the measured electric current value (charge amount). When the calculation
finishes, the measured result is shown on a display 35 and the sugar
blood level, for example, is able to be expressed in numerals. Finally,
the biosensor chip 10 is detached from the measuring device 31 and, since
the elastic body 20 returns at that time almost to the original height,
the state where the device for puncture 12 is not projected from an end
11a of the chip main body 11 is achieved. As a result, a user is able to
appropriately treat the biosensor chip 10 after use without being injured
by the device for puncture 12.

[0086]When the burden of the test body for the collection of blood is
taken into consideration, volume of the hollow reaction part 19 is
preferably not more than 1 μL (microliter) and, particularly
preferably, not more than 300 nL (nanoliter). When the hollow reacting
part 19 is as small as such, a sufficient amount of blood of the test
body is able to be collected even when the diameter of the device for
puncture 12 is small. Preferably, the diameter is not more than 1,000
μm.

[0087]When an end 11a of the chip main body 11 is pushed onto a test body
M in the above-mentioned biosensor chip 10 and biosensor system 30, the
elastic body 20 is compressed and the device for puncture 12 is projected
whereupon the test body M is able to be punctured. When the pushing force
is made weak, the device for puncture 12 is pulled out from the test body
M due to the resilience of the elastic body 20 whereupon the blood D is
flown out from the puncture opening. At that time, the puncture opening
and the sample collection opening 13 installed at an end 11a of the chip
main body 11 are enclosed in a tightly-closed space 23 formed by the
elastic body 20 and, when the elastic body 20 returns to its original
shape after the puncture, the inner area of the tightly-closed space 23
becomes a negative pressure whereby the blood D is able to be collected
from a very small puncture opening and pain of the test body M is able to
be reduced. In addition, even small amount of blood D is able to be
easily collected by the sample collection opening and analyzed and,
therefore, burden of the test body M is able to be reduced.

[0088]Further, when the device for puncture 12 is made not to project from
the front end 21 of the elastic body 20 before the use, protection of the
device for puncture 12 and protection of users are able to be achieved.
Furthermore, when the device for puncture 12 is made not to project from
the front end 21 of the elastic body 20 upon disposal after the use, it
is possible to dispose safely and adequately.

[0089]The biosensor chip of the present invention is not limited to the
above-mentioned embodiments only but may be appropriately modified,
improved, etc.

[0090]For example, in the above-mentioned embodiment, an example is shown
where the device for puncture 12 is installed in a spacer layer 17 being
sandwiched between both of the substrate plates 16a, 16b but the
biosensor chip 10 of the present invention is not limited thereto. For
example, it is also possible to install a device for puncture 12 along
the outer surface of one of the substrate plates 16a as shown in FIGS.
4(A) and (B). In the case of the biosensor chip 10B as such, it is
possible to reduce the thickness of the chip main body 11 whereby a thin
biosensor chip 10B is able to be formed. However, since the device for
puncture 12 and the sample collection opening 13 are somewhat apart, it
is desirable that a cross-sectional shape of the penetration hole 22 is
made rectangular or the like and the gap formed between the outer surface
of the device for puncture 12 and the inner surface of the penetration
hole 22 of the elastic body 20 is made as small as possible.
Incidentally, in FIG. 4, the sites which are common to those in the
already-mentioned biosensor chip 10 are assigned with the same numerals
whereby the duplicated illustrations are able to be omitted.

[0091]It is also possible that, as shown in FIG. 5, the shape of the part
of the elastic body 20 to be pushed onto the test body is made into a
curved or linear hollow 25 so as to enhance the adhesive property to
fingers. It is further possible that, as shown in FIG. 6, a columnar
hollow 25 is formed around the penetration hole 22 of the front end 21 of
the elastic body 20 so as to enhance the adhesive property to fingers.
Thus, it is now possible to efficiently collect the blood by forming a
hollow (gap) between the penetration hole which is a blood collection
opening of the elastic body and the fingers. That is particularly highly
effective when the collecting amount is small.

[0092]Still another embodiment of the elastic body is that, as shown in
FIG. 7, plural cuttings 27 are formed at the linear projected area 26
surrounding the penetration hole 22 of the front end 21 of the elastic
body 20 where the central part of the columnar hollow 25 is in a front
end direction and the cut grooves 28 are formed on the front end surface
21 whereby the resilience of the front end 21 and the projection 26 is
able to be enhanced.

[0093]A furthermore embodiment of the elastic body is that, as shown in
FIG. 8, the elastic body 20 is not necessary to be integrally formed by a
single type of a material but an elastic body having a function of
pulling out the device for puncture 12 from the test body and a path for
introducing the blood may be formed from different materials. Thus, it is
also possible that, as to the area which directly contacts the blood, an
expansion part 29 is formed by molding a material such as fluorine resin
used for artificial blood vessel, etc. into a pleated shape, a projection
26 is formed at the front end and then they are integrally molded with
the elastic body. It is still further possible that the biosensor chip
and the rubber elastomer are engaged each other so that the fixation is
made stronger.

[0094]In the above-mentioned embodiments, illustration is made for the
cases where the test body M or the like is punctured by pushing the
biosensor chips 10, 10B but an embodiment where the puncture is carried
out by a lancet is also possible.

[0095]Further, although the cases where collection is carried out by means
of surface tension or capillary phenomenon of the blood D are illustrated
hereinabove, it is furthermore possible to use a device such as a pump
which sucks the blood D which is flown out to a puncture opening. It is
still further possible that sucking is conducted when a tightly-closed
space 23 is made in reduced pressure.

[0096]Hereinabove, the present invention is illustrated in detail and also
by referring to specific embodiments but it is apparent for persons
skilled in the art that various changes and modifications thereof are
able to apply without departing from the spirit and the scope of the
present invention.

[0097]The present invention is based on the Japanese Patent Application
(No. 2006-113,915) filed on Apr. 17, 2006 and its content is incorporated
herein as a reference.

INDUSTRIAL APPLICABILITY

[0098]As mentioned hereinabove, an elastic body is installed at an end of
a chip main body in the biosensor chip of the present invention and,
therefore, the elastic body installed at an end of the chip main body is
compressed and a device for puncture is projected whereby a test body is
punctured. When the pushing force is made weak, the device for puncture
is pulled out from the test body due to the resilience of the elastic
body whereupon a sample is flown out from the puncture opening. At that
time, since the puncture opening and the sample collection opening
installed at an end of the chip main body are enclosed in a
tightly-closed space formed by the elastic body, there is achieved an
effect that even small amount of sample is able to be easily collected by
the sample collection opening and it is useful as a biosensor chip, etc.
which conducts the measurement and the analysis of chemical substances
using a reagent received in a hollow reaction part of the chip.